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Clinical Trials/NCT05114876
NCT05114876
Recruiting
Not Applicable

Redesigning the Surgical Pathway: Optimizing PReOperative assessMent in Anesthesia Clinic for adulT Surgical Patients (PROMoTE)

Sunnybrook Health Sciences Centre1 site in 1 country260 target enrollmentDecember 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
260
Locations
1
Primary Endpoint
Incidence of POD before and after implementation of an institutional prospective diagnostic program.
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

Cognitive complications, that is problems with thinking and memory, are incredibly common after surgery, occurring in 10-50% of all older surgical patients. These complications can take different forms, but one of the most common is postoperative delirium (POD), a short-term state of confusion. In addition to being stressful for patients and their families, POD is linked to longer hospital stays, increased costs, higher mortality rates and other problems after surgery. Despite this, POD is often not recognized by doctors and there are currently no effective medications to treat POD. However, simple strategies such as helping patients to sleep properly and remain hydrated, have been shown to help.

This study is testing if a delirium-reduction program will reduce postoperative delirium (POD) in older surgical patients. The investigators will first test memory and thought processes before surgery to find people who are most likely to develop POD. Once these people have been identified, they will be enrolled in a program which includes recommendations for their care team (e.g. surgeon, anesthesiologist, nurses) as well as educational materials for them and their family related to things that can be done to prevent delirium. By identifying at-risk patients and making sure that their doctors and caregivers are aware of how to prevent delirium, the investigators expect that this study will make surgery safer for older surgical patients.

Detailed Description

Postoperative delirium (POD), an acute, reversible disturbance in brain function characterized by fluctuating levels of consciousness, attention and cognition is a common postoperative complication in older surgical patients. POD is associated with increased morbidity, mortality, and risk of dementia; in addition to longer hospital stays and increased healthcare costs. Despite this, POD frequently goes unrecognized by healthcare providers and is often poorly proactively managed. There are currently no effective pharmacological treatments for POD, although non-pharmacological prevention strategies (e.g. promoting sleep hygiene, hydration, and early mobilization) have proven effective. This will be a two-phase, prospective, observational comparative study in patients (age ≥60) presenting for major, elective surgical procedures with an expected postoperative stay ≥1 day(s). In both phases, baseline cognitive screening will be used to identify individuals with evidence of pre-existing cognitive impairment (pre-CI), a key risk factor for POD, and only individuals with pre-CI will be eligible to continue in the study. Phase I will establish the prevalence of POD and pre-CI in our patient population at Sunnybrook Health Sciences Centre, a tertiary care academic health sciences centre, and act as a control group for Phase II. Phase II will evaluate the effects of a comprehensive delirium-risk prevention bundle, which includes direct-to-patient education and healthcare provider awareness strategies. Participants in both Phase I and Phase II will provide written/verbal informed consent. In each phase the study team will complete delirium assessments for 130 patients at baseline and on postoperative days 1-3. Demographic and clinical data will be abstracted from participants medical records. PHQ-9 (depression) and AD-8 (dementia screening interview) questionnaires will be completed at baseline.

Registry
clinicaltrials.gov
Start Date
December 13, 2021
End Date
December 1, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥ 60 years old
  • Undergoing major elective surgery (e.g., intra-abdominal, retroperitoneal, major orthopedic) with an expected postoperative stay of at least 1 night
  • Evidence of cognitive impairment on baseline screening tests (i.e. any score \< 90 on CBB or \>10 on S-OMCT)

Exclusion Criteria

  • Patients undergoing cardiac surgery
  • Patients undergoing intracranial neurosurgery
  • Patients with known substance use disorder (verbally declared by patients)
  • Unlikely to comply with study assessment (e.g., no fixed address, without access to internet/computer/phone).

Outcomes

Primary Outcomes

Incidence of POD before and after implementation of an institutional prospective diagnostic program.

Time Frame: twice daily on postoperative days 1-3, morning/late afternoon

POD evaluated by 3D-CAM and retrospectively using the CHART-DEL method

Secondary Outcomes

  • Hospital length of stay(Until discharge, average of 1 week)
  • Unit adherence rate to CHASM principles(Until discharge, average of 1 week)
  • Delirium Severity(twice daily on postoperative days 1-3, morning/late afternoon)

Study Sites (1)

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